On August 9, 2021, the Food and Drug Administration (FDA) issued FDA Circular (FC) No. 2021-002-A, establishing guidelines for the application process of a Certificate of Medical Device Notification (CMDN) and a Certificate of Medical Device Registration (CMDR) for Class B, C, and D medical devices that were not part of the registrable devices listed in FC No. 2020-001-A. This was in line with the full implementation of Administrative Order (AO) No. 2018-0002.
To prevent potential disruptions in the supply of medical devices in the market due to the provisions in FC No. 2021-002-A, the FDA subsequently released FC No. 2021-002-B on April 21, 2022. This circular granted regulatory flexibility to all Class B, C, and D medical devices not included in the registrable list under FC No. 2020-001-A and already available in the market before FC No. 2021-002-A was enacted.
Further regulatory flexibility was provided with FC No. 2021-002-C, issued on March 29, 2023. This allowed for an extension of the application periods for CMDN and CMDR for Class B, C, and D medical devices not listed as registrable in FC No. 2020-001-A. This extension offered medical device industries sufficient time to prepare the necessary technical documentation required for CMDR applications.
As the deadlines outlined in FC No. 2021-002-C are approaching, the FDA acknowledges the critical need to ensure the uninterrupted availability of medical devices. Recognizing the necessity of extended regulatory flexibility, the FDA intends to assist the medical device industry in meeting the requirements for CMDN and CMDR applications in accordance with the ASEAN Common Submission Dossier Template (CSDT).
II. OBJECTIVE
This Circular provides detailed guidelines for extending the regulatory flexibility applicable to the specified medical devices outlined in Section III.
III. SCOPE
This issuance applies to all Class B, C, and D medical devices not listed as registrable in FDA Circular No. 2020-001-A.
IV. DEFINITION OF TERMS
For implementing this Circular, the terms used shall be defined as specified in FC No. 2021-002-C, Republic Act No. 9711, its Implementing Rules and Regulations (IRR), and other relevant laws and regulations.
V. GUIDELINES
A. All Class B, C, and D medical devices excluded from the registrable list in FC No. 2020-001-A may continue to be manufactured, imported, exported, distributed, transferred, sold, or offered for sale without a CMDN until September 30, 2024. The License to Operate (LTO) for the medical device establishment must be presented at the point of entry (to the Bureau of Customs) and/or as part of the bidding requirements.
B. Applications for CMDN for Class B, C, and D medical devices covered by this Circular shall be accepted up until September 30, 2024.
C. Submissions for CMDN applications for these medical devices will cease on October 1, 2024. Establishments may choose to apply for a CMDR in place of CMDN for their products before this deadline.
D. Starting October 1, 2024, all manufacturers, traders, exporters, importers, and distributors must apply for CMDR for the specified Class B, C, and D medical devices.
E. From October 1, 2024, the manufacture, importation, exportation, distribution, transfer, sale, or offering for sale of any Class B, C, and D medical devices under this Circular without a CMDN, CMDR, or a pending application for CMDN/CMDR will be strictly prohibited. A pending application refers to those with proof of payment and a document tracking number.
F. Market Authorization Holders (MAH) with valid CMDNs for Class B, C, and D medical devices must apply for a CMDR at any time within the CMDN’s validity period to ensure continuous market authorization during this transition. While the CMDR is under review, the MAH may continue manufacturing, importing, exporting, distributing, and selling the product. The issued CMDN and proof of payment for CMDR must be presented at the point of entry and/or as part of the bidding requirements.
G. During the CMDR application process, the MAH shall submit a letter indicating that the application is transitioning from CMDN to CMDR, along with a copy of the CMDN.
VI. SEPARABILITY CLAUSE
If any section, term, or provision of this Circular is declared invalid or unenforceable, the remaining sections and provisions shall remain in effect. The Circular will be interpreted as if the invalid, unenforceable, or unconstitutional part was not included.
VII. REPEALING CLAUSE
Section V (Items A, B, C, D, E, and F) of FDA Circular No. 2021-002-C are at this moment modified, repealed, and/or revoked accordingly.
VIII. EFFECTIVITY
This Circular shall take effect fifteen (15) days after its publication in the Official Gazette or any newspaper of general circulation and upon filing with the University of the Philippines Law Center, Office of the National Administrative Register.
